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Michael Greenstein, Ph.D., is the Laboratory Director of the Sensing and Diagnostics Laboratory (SDL) in the Biosciences Division of SRI International and has over 26 years of experience in the development and commercialization and program management of IVD medical devices. In his career, Greenstein has worked on microfluid, lateral flow assay, molecular diagnostics, and ultrasonic imaging (transthoracic and intravascular) medical device programs.
Dr. Greenstein is currently the co-PI of BARDA programs sponsored by HHS/BARDA on a triage radiation biodosimeter and an anthrax detection. Other projects in SDL include a portable DNA/RNA epigenetic sequencer, an interstitial fluid patch assay, and microbiome measurements. SDL also has a full medical device Quality Management System (QMS), appropriate for FDA approved medical devices, as well as experience in interacting with FDA.
Prior to joining SRI, Greenstein was the CTO of Wako Life Sciences, a US subsidiary of a Japanese IVD company where he managed the R&D, IT, IP, Quality, and Regulatory groups, supporting the development of microfluidic chip-based Immunoassay and Molecular Diagnostic IVD systems. These systems have received regulatory approval in Japan and the US. Prior to this Greenstein was employed at Applied Biosystems, Caliper Life Sciences, Agilent Technologies and Hewlett-Packard, working on a variety of biotechnical and medical devices.
Dr. Greenstein holds a Ph.D. in physics from the University of Illinois at Urbana-Champaign and an AB in physics from the University of California at Berkeley. He was a postdoctoral research fellow at the University of Illinois at Urbana-Champaign where he built a picosecond laser amplifier system and studied electron / photon / phonon interactions at ultralow temperatures. He is the inventor/co-inventor on 46 US patents, and the author/co-author on 28 peer reviewed published papers.
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